On 14 December 2023, Council and the European Parliament reached a major political agreement on the Substances of Human Origin (SoHO) Regulation. This Regulation will replace the Blood Directive and the Tissues and Cells Directive, combining both legal texts into one. In addition, the Regulation will extend its protection to any SoHO regardless of whether it meets the definition of âbloodâ, âtissueâ or âcellâ to avoid that certain groups of donors or recipients are left…
On 13 December 2023, the German government published a long-awaited strategy outline of intended upcoming legislative measures to counter both the dwindling significance of Germany as a strong hub for pharmaceutical innovation, and threats to supply chain security. The proposed action items fall into 8 chapters, the most significant of which for pharmaceutical companies are briefly summarised below: 1. Strengthening clinical research; a model clinical trial agreement and centralised ethics committee The government intends to…
In Brief In a judgment of 18 October 2023 (T-74/21), the EU’s General Court roundly dismissed the appeal by Teva and Cephalon against the European Commission’s 2020 decision imposing fines of approximately âŹ30 million on each of them for concluding an anti-competitive patent settlement agreement back in 2005. In some ways the case is an historic relic: since the US Supreme Court’s 2013 ruling in Actavis and the Commission’s decision a few days later in…
The Court of Justice of the European Union (CJEU) has recently issued a judgment clarifying that wholesale distributors may not obtain medicines directly from pharmacies that do not hold a wholesale distribution licence (WDA). This represents a useful confirmation of the current law, a rule that is set to remain under the new EU Pharmaceutical Package. With its judgment dated September 21, 2023 (Case C-47/22), the CJEU ruled on the interpretation of Article 80, first…
The European Medicines Agency (EMA) has published a draft reflection paper which considers the application of artificial intelligence (AI) and machine learning (ML) to the development, regulation and use of medicines. This paper, which is now open for public consultation, evaluates the risks, benefits and opportunities that AI and ML present to the entire lifecycle for medicines. Underlying the paper is EMA’s concern around the challenges of integrating AI and ML into the medicines lifecycle,…
In the third and final post of our ‘Kick Start your Healthcare Reorganisation’ series, we focus on the post-implementation matters often encountered on healthcare and life sciences reorganisations. These range from the many regulatory requirements through to ensuring steps are taken to realise the maximum value from the reorganisation. These post-implementation matters often bring us back to, and illustrate the importance of, careful early planning and seamless implementation. When conducting a multi-jurisdictional reorganisation in the…
In the second post of our ‘Kick Start your Healthcare Reorganisation’ series we focus on the implementation phase of a healthcare and life sciences reorganisation and specifically the following three areas: Whilst each area is individually significant, and is likely to have its own dedicated workstream, it is important to recognise that they each go hand in hand when looking to achieve smooth (and successful) implementation. Document execution First, on multi-jurisdictional projects, with a large…
On 25 July 2023, the EU Commission published its response to the European Citizensâ Initiativeâs petition on âSave Cruelty-free Cosmetics – Commit to a Europe without Animal Testingâ. The petition received 1.2 million signatures from EU citizens and the EU Commission must respond to petitions gathering 1 million signatures or more. The EU Commission has confirmed the following in response to the requests of the petition: Protect and strengthen the cosmetics animal testing ban Transform…
Last month, the UK House of Commons debated the current state of regulatory and legal hurdles negatively affecting the development of psilocybin-based (the psychedelic compound most commonly found in âmagic mushroomsâ) therapies for mental and physical health disorders in the UK. The debate resulted from an e-petition, which garnered 11,824 votes in February this year. The debate saw a consensus among Members of Parliament across party lines, collectively supporting the proposal for rescheduling psilocybin from…
In the first post of our ‘Kick Start your Healthcare Reorganisation’ series we focus on the planning phase of a reorganisation in the healthcare and life sciences sector in the context of spin offs, carve outs and other solvent group restructurings. It goes without saying that when preparing for a large reorganisation there is a significant amount of planning required to ensure seamless transition and continuity of supply chain. The industry is heavily regulated which…